ABSTRACT
The objective of any drug-delivery system is to deliver in vivo the active drug moiety to the target tissue or receptor site. Whether the delivery system is simple or sophisticated, it is the responsibility of the formulator, and other product development support functions, to design a drug-delivery system capable of consistently achieving the desired pharmacokinetic-pharmacodynamic profile as an outcome of formulation and manufacturing process development and optimization. To achieve a robust formulation and reproducible product manufacturing in which product quality specifications are consistently met is not always an easy and straightforward exercise. Driven by formulation obstacles, processing complexities, an ever-increasing regulatory environment, health care cost-containment measures, and other pharmacoeconomic challenges can certainly influence the approach to and outcome of both product and process development. To achieve rapid and successful development of a drug-delivery system, there is an increasing focus on experimental design techniques, product scale-up planning, and process technology transfer activities. Additionally, and often considered the bane of many projects, is cost. This financial aspect is mentioned because there is a growing requirement within the pharmaceutical industry in specifying target values for manufacturing costs as early as possible within the life cycle of a project that could constrain the final production process. A knowledge of the effect of cost, estimated or otherwise, ensures not only that the criteria for efficacy, safety, and quality of a product are achieved, but also that the economic and environmental implications in product manufacturing are understood and deemed acceptable. It further augments the necessity in the implementation of well-planned, systematic methods, and the definitive need for understanding the performance characteristics and the critical aspects of manufacture of a product, particularly in its scale-up and transition to the production environment.
